IMMULITE 2000 XPI
Received Nov 10, 2015 · Event occurred Oct 16, 2015
Report 2247117-2015-00062 · MDR key 5213678
Device
Generic name
Immulite 2000 Xpi
Manufacturer
Siemens Healthcare Diagnostics Inc.Model number
IMMULITE 2000 XPICatalog number
030001-3
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
A SIEMENS TECHNICAL ASSAY SPECIALIST (TAS) WAS DISPATCHED TO THE CUSTOMER SITE. THE TAS WORKED WITH THE CUSTOMER, AND RAN HCG CALIBRATION VERIFICATION MATERIAL (CVM) FOR ASSAY LINEARITY, QUALITY CONTROL SAMPLES, AND PATIENT SAMPLES PROVIDED BY THE CUSTOMER. AS THE CUSTOMER HAD TWO IMMULITE 2000 XPI'S THE STUDY WAS CARRIED OUT ON BOTH INSTRUMENTS, AND THE RESULTS ON BOTH INSTRUMENTS WERE WITHIN SPECIFICATIONS. THE CAUSE OF THE DISCORDANT HCG RESULTS IS UNKNOWN. THE SYSTEM IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.
Description of Event or Problem
THE CUSTOMER HAS OBTAINED DISCORDANT RESULTS ON PATIENT SAMPLES FOR THE HUMAN CHORIONIC GONADOTROPIN (HCG) ASSAY ON AN IMMULITE 2000 XPI INSTRUMENT. THE CUSTOMER INDICATED THAT THE RESULTS WERE DISCORDANT AT THE LOW END OF THE ASSAY <5 IU/ML AND AT THE HIGH END. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT RESULTS OBTAINED ON THE IMMULITE 2000 XPI.